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Study of RAD001 in Soft Tissue Extremity and/or Retroperitoneal Sarcomas

2014-08-27 03:16:40 | BioPortfolio

Summary

The goal of this clinical research study is to learn if the study drug RAD001 can stop or slow the growth of resectable soft tissue sarcoma. The patient's physical state, their symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if RAD001 is safe and effective in patients with this condition. The study drug, RAD001, is made by Novartis Pharmaceuticals Corporation.

Description

A single-arm, open label, proof of principle phase II study exploring the efficacy of RAD001 in resectable soft tissue sarcomas either in the extremities, trunk or retroperitoneum. Patients with resectable sarcomas as detailed below will have a core biopsy for molecular markers prior to therapy with RAD001 10mg PO daily x 4 weeks. The patients will then be brought to surgery for definitive resection within 21 days of the end of therapy with RAD001. Pharmacodynamic markers as detailed in the objectives will be assessed in the laboratory.

Patients will be numbered sequentially from 1 to 40, or more if there are patients that drop out due to drug toxicity, with the goal of achieving 40 pts in accrual for evaluation of the pre- and post-treatment tumor samples for Pharmacodynamic assays.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Sarcoma

Intervention

RAD001

Location

H. Lee Moffitt Cancer Center and Research Institute
Tampa
Florida
United States
33612

Status

Recruiting

Source

H. Lee Moffitt Cancer Center and Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:40-0400

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Medical and Biotech [MESH] Definitions

An experimental sarcoma of mice.

An experimental sarcoma of mice.

An experimental sarcoma of rats.

Experimentally induced neoplasms of CONNECTIVE TISSUE in animals to provide a model for studying human SARCOMA.

A family of transforming proteins isolated from retroviruses such as MOUSE SARCOMA VIRUSES. They are viral-derived members of the raf-kinase family of serine-theonine kinases.

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